CSL Behring Announces New Vial Size of Privigen® for Treatment of Primary
Immunodeficiency and Chronic Immune Thrombocytopenic Purpura
New 40 gram (400 mL) size provides a convenient option that reduces complexity
of administration for pharmacists and infusion nurses
KING OF PRUSSIA, Pa., Feb. 21, 2013
KING OF PRUSSIA, Pa., Feb. 21, 2013 /PRNewswire/ --CSL Behring today
announced that the United States Food and Drug Administration has approved a
40 g (400 mL) vial size for Privigen®, immune globulin intravenous [human].
The new vial size will simplify preparation and administration of the product
when high volumes of it are required. Privigen is approved for the treatment
of patients with primary immunodeficiency (PID), a group of rare and serious
diseases of the immune system, and provides effective protection against
infection by assisting the body in maintaining a normal level of
immunoglobulin. Privigen is also approved in the United States for chronic
immune thrombocytopenic purpura (ITP) to raise platelet counts. With the
addition of the 40 g vial, Privigen will be available in four sizes in the
United States, including 5 g (50 mL), 10 g (100 mL) and 20 g (200 mL). The
first supply of Privigen in this new vial size will be introduced in June.
"CSL Behring strives to bring new innovations to the healthcare marketplace
and deliver products that enhance the patient experience," said Val Romberg,
Senior Vice President, Research and Development. "The 40 gram vial size for
Privigen continues that commitment by reducing the complexity of
administration and increasing time savings for healthcare providers."
Privigen can be administered through pooled infusion using intravenous (IV)
bags or through individual vial infusion – hung separately from the IV line.
Patients who are administered Privigen are dosed based on body weight. For
patients who require high doses of Privigen, the 40 g vial size of Privigen
will reduce the required number of individual vial infusions or the need to
pool multiple vials for an IV bag infusion.
Privigen® is the first and only 10 percent liquid IVIg stabilized with
proline, a naturally occurring amino-acid. In the US, Privigen is indicated as
replacement therapy for patients with primary immunodeficiency (PID)
associated with defects in humoralimmunity. Privigen is also indicated to
raise platelet counts in patients with chronic immune thrombocytopenic purpura
WARNING: Use of Immune Globulin Intravenous (IVIg) products, particularly
those containing sucrose, have been associated with renal dysfunction, acute
renal failure, osmotic nephropathy, and death. Privigen does not contain
sucrose. Administer Privigen at minimum rate practicable in patients at risk
of renal dysfunction or acute renal failure. At-risk patients include those
with preexisting renal insufficiency, diabetes mellitus, volume depletion,
sepsis, or paraproteinemia; over 65 years of age; or receiving known
nephrotoxic drugs. See full prescribing information for complete boxed
Privigen is contraindicated in patients with history of anaphylactic or severe
systemic reaction to human immune globulin, in patients with hyperprolinemia,
and in IgA-deficient patients with antibodies to IgA and history of
Privigen is derived from human plasma. The risk of virus transmission cannot
be completely eliminated.
In clinical studies of patients being treated with Privigen for PI, the most
serious adverse reaction was hypersensitivity (one subject) Adverse reactions
observed in >5% of subjects with PI were headache, pain, nausea, fatigue,
chills, vomiting, joint swelling/effusion, pyrexia and urticaria.
For more information about Privigen, including full prescribing information,
About CSL Behring
CSL Behring is a leader in the plasma protein therapeutics industry. Committed
to saving lives and improving the quality of life of people with rare and
serious diseases, the company manufactures and markets a range of
plasma-derived and recombinant therapies worldwide.
CSL Behring therapies are used around the world to treat coagulation
disorders, including hemophilia and von Willebrand disease, primary immune
deficiencies, hereditary angioedema and inherited respiratory disease, and
neurological disorders in certain markets. The company's products are also
used in cardiac surgery, organ transplantation, burn treatment and to prevent
hemolytic disease of the newborn. CSL Behring is a subsidiary of CSL Limited,
a biopharmaceutical company with headquarters in Melbourne, Australia. For
more information, visit www.cslbehring.com. CSL Behring operates one of the
world's largest plasma collection networks, CSL Plasma.
Sheila A. Burke
Director, Communications & Public Relations
Worldwide Commercial Operations
SOURCE CSL Behring
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